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Bioequivalence study of OP-10 in healthy male adults

OP-10-002 Study

Taguchi Fumi

OHARA Pharmaceutical Co.,Ltd.

36F St.Luke's Tower 8-1, Akashi-cho, Chuo-ku, Tokyo, Japan

chiken@ohara-ch.co.jp

Department of Clinical Development

OHARA Pharmaceutical Co.,Ltd.

36F St.Luke's Tower 8-1, Akashi-cho, Chuo-ku, Tokyo, Japan

+81-3-6740-7701

chiken@ohara-ch.co.jp

Complete

May. 20, 2024

Interventional

non-randomized controlled trial

open(masking not used)

active control

crossover assignment

other

1) Healthy Japanese male.
2) Age at the time of obtaining written informed consent is >= 18 to <= 40 years old.
3) BMI at time of screening is >= 18.5 to < 25.0.
4) Agreement to use contraception and refrain from sperm donation between Day 1 of Period 1 and 180 days after the last dose of study intervention.
5) Written informed consent to participate in this trial can be obtained.

1) History of allergy to investigational drug ingredients, drugs, or foods.
2) History of or undergoing treatment for any diseases of respiratory, circulatory, central nervous system, gastrointestinal, hepatic, renal, hematological, or endocrine disorders that affect pharmacokinetics.
3) Other protocol defined exclusion criteria could be applied.

Male

Recurrent or exacerbated diffuse midline glioma

A single oral dose of 1 capsule of OP-10(JP) or OP-10(US) will be adminisrated with approximately 150 mL of water under fasting for at least 10 hours on Day 1 of each 6-day period in Period 1 or Period 2.

Pharmacokinetics (Cmax, AUC(0-t)) of OP-10

(1)Pharmacokinetics (2)Safety

+81-92-283-7701

Mar. 25, 2024

No

none